Harmonization and implementation of the directives

about dangerous substances, carcinogens and explosive

atmospheres Difficulties and suggestions

Dr. Gyula Körtvélyessy

Honorary Secretary General

Hungarian Chemical SocietyMSzT

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Review• General overview about definitions,

legislations and processes• Short summary of the Directives• Implementation problems because of the

own national systems– Linguistic– In timing– Legislative– In enforcement

• Main elements of the best practices learned

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Risk assessment, in general• Poisoning, Fire, Explosion, Cancer,

Unusable legislations, Standards not convenient for our company PROBLEMS

• How to avoid them– Preventive actions– Corrective actions– Think first to avoid later damages!

• Tool: risk assessment

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Substance

Preparation

Subst1

Subst2

Subst3

Use 1 Pharmaceuticals

Use 2Paints

Flammable

Toxic

CarcinogenicUse 3

Construction materials

Hazard Function

Drugs Directive

VOC Regulation

RoHS Directive

REACH

67/548 - GHS

Worker Safety

Article

Use 4 Equipment

Dangerous equipment Directive

Sharp, moving, hitting

SEVESO

ADR

Carcinogen Directive

Fire protection

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Main types of European legislative tools

• Directives National legislations: Acts + Decrees

• Regulations Valid immediately in the Member States

• Harmonized standards How to put the legislation into practice in an acceptable way?

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Parliament Council Harmonized standards

Lobbying

Turkish Federations Turkish

Standardization Institute

Cefic

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Activities in the processing industry

Nature Basic chemicals

Active ingredients

Preparations

Parts

MiningChemical

transformations

Chemical transforma

tions

Equipment

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From petrochemicals to paints and car-making

Crude oilToluene, Propene

AcrylatesPolyacrylates

Paint

Parts

MiningCracking

Chemical transforma

tions

Equipment

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Terms and Definitions in the Directives

• 1999/92: (flammable) substances

• 1998/24: chemical agents: substances + preparations

• 1990/394: carcinogens: substances + preparations R45: „may cause cancer”

• 1997/42: carcinogens C-1 and C-2

• 1999/38: + mutagens

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Terms and definitionsChemical agents

Hazardous chemical agents

Hazardous substances and preparations in the meaning of 67/548 Directive but not those dangerous to environment

Any substances or preparations present risk to the workers or having occupational exposure limits

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Hazard and Risk

• 'Hazard` means the intrinsic property of a chemical agent with the potential to cause harm

• `Risk` means the likelihood that the potential for harm will be attained under the conditions of use and/or exposure

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Hazard and risk

LD50=6-8 g/kg 500 g/70kg1L Pálinka

Exposure!!!

S2: Keep out of the reach of children.

S7: Keep container tightly closed!

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Which chemical agents?• Produced intentionally or not intentionally

– Separating from nature– Chemical reactions– Mixing

• Released– As a waste

• Used• Independently from placing on the market or not

– Marketed products– By-products– Wastes– Internal products

Through work activities

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Tasks in the DirectivesRisk assessment

• Identification of the chemical agents present on the workplace• Identification of the hazardous properties of the agents

– MSDS– Occupational exposure limit values – Literature

• The level, type and duration of exposure– Endpoints (skin, lung, digestion, etc.)– Measured airborne concentrations if available

• The effect of preventive measures taken or to be taken– Substituting substances, processes– Reduction of level of exposure by technical, administrative measures– Reduction of the number and time of exposure of workers….– Personal protective equipment– Training– Monitoring exposure level at workplace, workers exposure

• Risk evaluation– Ratio of the exposure to the acceptable level < > = 1

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Substance

Measure the acceptable parameters to given endpoints of the given workers group(s)

NO EFFECT LEVEL

>?<?=?

Compare!

Risk AssessmentMeasure the exposure on the workplace to the given exposure routes

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Distributions of occupational diseases

Chemical

Physical

Biological

Other

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Transposing problems: language

• Chemicals, Chemical agents, Substances, Materials, Matter, Compounds, Components, Constituents

• Preparations, Mixtures, Blends• Anyag, Vegyület, Vegyszer, Kemikália,

Komponens, Összetevő• Készítmény, Keverék, Blend

• Take care of the translations of legislations!

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Transposing problems: Timing

1970 1980 1990 2000 2010 2020

Publications of directives

Ten Joining

Countries2004

Two Joining

Countries2008

Turkey Joining

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Transposing problems: Structure of national legislation system

0

10

20

30

40

50

60

70Number of national legislations

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Transposing problems: Structure of enforcement system

Equipment safety

Seveso

Health

Environment

Fire brigades

All separate enforcement institutions

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Transposing problems: Extra national measures

• Hungary:– Extra notification to national authority about

hazardous chemicals and preparations used– Extra transfer of MSDS to national authority– More stringent occupational limits for chemicals– More stringent measures for fire safety

• Turkey:– Do not follow it!– Competitive disadvantage for the national

industry

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Solutions 1: Preventive measures

• To „install” health and safety into your processes from the very beginning– Check every stage of scale-up by HSE people

• Do not use „bad” chemicals in R and D– Carcinogens, Mutagens and Toxic for Reproduction– Persistent, Bioaccumulative and Toxic– Highly Flammable chemicals and solvents– Any solvents

• Use normal conditions if possible– Temperature, pressure

• Advantages of continuous process

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Solutions 2: Databases• Product database

– Add subtance(s) content known to your products– Add CAS, EC data of substances– Add health and safety data

• Workplace database– List of dangerous or not dangerous equipment– List of processes running– Noise data– Workplace air monitoring data

• Worker database– Health monitoring data of the exposed – Biological monitoring– Time of exposure to carcinogens– Exposure monitoring data

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Solutions 3: Management systems• Quality management system

– System available for recording everything

– Clean processes (to avoid contaminations and cross-contamination)

• Environmental and Safety Management Systems– Practice for continual improvement– Established performance indicators

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Solutions 4: Technical development• General technical development helps

with improving workplace conditions– Better sealing Less released

chemicals– Automatic control Safer process

management– Automatic centrifuging no exposure– Automatic sampling no exposure– Better ventilation system less

exposure– Better personal protective equipment

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As a last option

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Thank you for your kind attention!